HHV-8 (13810) recall
HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte…
Why was HHV-8 (13810) recalled?
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1.0 ml lot 1626403D, expiry 2019-08; 7.0 mL lot. 1625207H, expiry 2019-08;
- Product
- HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte…
- Recalling firm
- Cell Marque Corporation
- Quantity
- 11
- Distribution
- Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
- Recall date
- June 7, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)